Financial Conflict of Interest Training

At the completion of this training course, you will be able to:◦ Recognize the requirements that guide Chicago

State University’s Financial Conflict of Interest (FCOI) policy and processes.◦ State who is subject to these FCOI requirements. ◦ Describe what is meant by the terms “significant

financial interest (SFI)” and “financial conflict of interest (FCOI)”.◦ State where and when SFIs must be disclosed and

how they are reviewed and managed.◦ Describe implications for noncompliance with

sponsored research COI requirements.

The Public Health Service and the National Science Foundation require CSU to provide all investigators who seek funding through their agencies training related to Financial Conflict of Interest.

The CSU policy on Financial Conflict of Interest has been revised to meet the PHS disclosure requirements. This training was developed to provide an overview of the policy.

The policy can also be viewed at:

◦ http://www.csu.edu/irb/fcoi

Investigators applying to or funded by Public Health Service agencies, the National Science Foundation and some private sponsors are also required to complete the NIH FCOI Tutorial: ◦ National Institutes of Health◦ Health Resources and Service Administration◦ Private sponsors that use PHS regulations: American Heart Association American Cancer Society

You must also complete the NIH FCOI Tutorial and submit a certificate of completion to the CSU Office of Sponsored Programs.

The NIH FCOI Tutorial can be accessed at:◦ http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm

An ‘investigator’ at CSU is defined as:◦ A Project Director◦ A Principal Investigator◦ Any person responsible for the design, conduct

or reporting of research◦ Subgrantees, consortium participants,

collaborators or consultants Individuals employed by institutions of higher education

should complete the training programs offered at their home institutions

Research conducted at CSU is covered by this regulation, including:◦ Basic and applied research, and◦ Product development.

Significant Financial Interests are disclosed by investigators.

Financial Conflict Of Interests are identified, eliminated or managed.

A significant financial interest (SFI) is:◦ an interest in an entity outside of the University where an

individual receives financial benefit or holds the potential for financial benefit that meets a defined threshold.

Per CSU policy, this includes:◦ For a publicly traded entity: Remuneration valued at $5,000 or more in the last 12 months; or Equity interest valued at $5,000 or more; or A combination of remuneration and equity that is valued at $5,000

or more.

◦ For a non-publicly traded entity: Remuneration valued at $5,000 or more in the last 12 months; or Any equity interest.

◦ For intellectual property rights and interests: Any income received related to such rights or interest.

Significant financial interests (SFI) are disclosed for:◦ The investigator and◦ The investigator’s immediate family members Spouse Dependent children

A Financial Conflict Of Interest (FCOI) means an SFI that could directly and significantly affect the design, conduct, or reporting of research.

Detailed information about the financial conflict of interest federal regulations can be found at: ◦ http://grants.nih.gov/grants/policy/coi/index.htm

The CSU FCOI Policy addresses potential FCOI sources, including:◦ Purchase/procurement of goods or services◦ Investments or loans made by the University◦ Research protocols submitted for review/approval◦ University technology or other intellectual property

agreements subject to negotiation◦ Donor contributions in support of scholarly

activities

Investigators have 2 requirements: ◦ Disclosure of SFI ◦ Completion of Training

Investigators in research projects funded by PHS, NSF or other funders that subscribe to PHS regulations must complete financial disclosures

What?◦ CSU Financial Conflict of Interest Disclosure Form can be

accessed at: http://www.csu.edu/irb/fcoi When?◦ At the time a proposal is submitted◦ Annually when progress reports are filed◦ Within 30 days of acquiring or discovering a new FCOI

How?◦ Submit the CSU Disclosure Form to the Office of

Sponsored Programs

The CSU Office of Sponsored Programs will review Financial Conflict of Interest Disclosure Forms.

If a significant financial interest (SFI) is identified, the CSU Office of Sponsored Programs will work with the investigator to eliminate the conflict or develop a management plan.

What?◦ Investigators are required to complete this training module and submit the certificate of completion to the CSU Office of Sponsored Programs.

◦ Investigators may be required to complete the NIH FCOI training module and submit the certificate of completion to the CSU Office of Sponsored Programs. http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm

When? ◦ Training must be completed: When an investigator is new to an

institution even if completed at another institution

Before engaging in research funded by agencies that require training/disclosure and then at least every four years

If Institutional FCOI policies change and the change affects Investigator requirements

If an investigator is not in compliance with FCOI policy or a FCOI management plan Read the CSU Financial Conflict of Interest Policy at

http://www.csu.edu/irb/fcoi

If an investigator fails to comply with an Institution’s conflict of interest policy or a financial conflict of interest management plan has biased PHS-funded research:◦ The Institution will notify PHS of planned corrective

action.◦ PHS and/or HHS may make inquiries about an

investigator or review records at any time and may suspend funding or take other actions.

An Investigator who:◦ fails to make required disclosures or◦ violates policy provisions may be subject to appropriate sanctions, including but not limited to:◦ discipline for misconduct and/or insubordination under

the University policies, practices and procedures, up to and including dismissal.

An investigator who disagrees with a decision regarding the existence of a SFI or FCOI or the necessary elements of a conflict management plan may submit a written appeal to CSU.

If you have questions about the CSU FCOI policy, training or reporting requirements:◦ Contact the CSU Office of Sponsored Programs Phone:773-995-2497

I certify that I have carefully read and reviewed the content of, and completed the

Chicago State University Financial Conflict of Interest Training Course

Furthermore, I certify that I understand my failure to comply with the laws, rules, policies and procedures referred to within this training course may result in disciplinary action in accordance with the policy.

Name: _________________________________________ Signature: _________________________________________Print: last name, first name, middle initial

Today’s Date: _______________ Date of Birth: ________________________ UID: _________________________mm/dd/yy mm/dd University ID Number

To be properly credited for participating in CSU FCOI training, please complete and return the original signature page to the Chicago State University Office of Sponsored Programs, ADM 303. Please keep a copy for your records.